C105 – GENERAL CHECKLIST: A2LA POLICY ON ...gcc-accreditation.net/uploads/site_documents/AC/Forms/AC... · Web viewThese uncertainties shall include an explanation of the meaning

Accreditation Procedures GAC

AC 4.3 Assessment Checklist forTraceability of measurements

Laboratories are required to meet the following additional requirements as contained in GAC Technical note 2 - Traceability of measurements .

GAC Assessor Instructions: Please note that for all N/A indications, you must document the reason why this requirement is N/A in the comments section.

To the best of my knowledge, all laboratory document references below as well as actual laboratory practice have been assessed for compliance with the relevant clauses of GAC Technical note 2 - Traceability of measurements. I hereby attest that all ‘Yes’ marked compliance clauses, whether initialed or not, meet the aforementioned requirements. Any areas of noncompliance have been fully described in the assessment Report.

CAB Name:Address:

Contact:Phone: Email:

Master Code: Assessment ID:Certificate(s): Conformity

Standard:Assessment Dates:

Assessment Type:

Assessor(s): Assessor Signature(s):

:

Version: 1 Page 1 of 16

Date: 11 October 2015

Approved by: Brahim Houla



Requirement

{RESERVED FOR GAC ASSESSORS ONLY}

ComplianceComments

Y N NA

T1. Purpose

This policy applies to:

all GAC applicant and accredited facilities;

all measurements, whether physical, chemical or biological etc…

calibrations performed by a facility for its own activities and which are not part of its scope of accreditation (so called “in-house calibrations”).

T2. Policy for traceability when performing calibrations

For equipment and reference standards that have a significant effect on the reported result and associated uncertainty of measurement shall be calibrated by one of the following:

Services which are subject to peer review

a) An N MI whose service is suitable for the intended need and is covered by the CIPM MRA. Services covered by the CIPM MRA can be viewed in Appendix C of the BIPM KCDB which includes the range and uncertainty for each listed service.

b) An a ccr e d i t e d ca l i bra t i o n l a b o r at o r y whose service is suitable for the






Requirement


ComplianceComments

Y N NAintended need (i.e. the scope of accreditation specifically identifies the appropriate calibration) and accredited by GAC or an accrediting body covered by the ILAC MRA for calibration.

Services which are not subject to peer review

The following two options should only be applicable when options a) and b) above are not possible for a particular calibration.

c) A n N MI whose service is s u i t a b l e for the intended need but n o t c o v ered by the CIPM MRA.

1. d) A n o n - a ccr e di t ed c a l i brat i o n l a b o r a t o r y whose service is suitable for the intended need but under the following conditions:

a) The CAB maintains evidence that there is no other accredited calibration laboratory available to perform the calibration or maintains evidence of qualification for special circumstances (see Policy on: Special Circumstances below); and

b) The CAB maintains evidence of a calibration certificate that contains all of the following (Note: Implementation begins with CABs that have an anniversary date of April 30, 2016 or later or new applications received after April 30, 2015):1. The calibration result; and,2. The measurement uncertainty reported as the expanded

uncertainty with a defined coverage factor, “k” (typically k = 2) and a confidence interval (typically to approximate the 95% confidence level); andVersion: 1 Page 3 of 16





Requirement


ComplianceComments

Y N NA3. An indication of the reference standard(s) used to perform

the calibration; c) The CAB maintains evidence that the reference standard(s)

noted on the calibration certificate are traceable to the SI through any of GCC NMIs (or equivalent) or an accredited

laboratory; d) The CAB maintains evidence of the calibration interval1 for the

measuring and test equipment (M&TE) or reference standard (Note: Implementation begins with CABs that have an anniversary date of April 30, 2016 or later or new applications received after April 30, 2015).

T3. Policy for traceability when performing tests and measurements

For tests and measurements:

e) If the results of calibration of equipment used contributes significantly to the overall uncertainty, the same policy for traceability applies (as detailed above).

f) If the result of a calibration is not a dominant factor in the test or measurement result, the facility shall have quantitative evidence to demonstrate that the associated contribution of the calibration contributes little (insignificantly) to the test or measurement result and

1 See, for example, NCSLI RP-1 "Establishment & Adjustment of Calibration Intervals" (3/96).






Requirement


ComplianceComments

Y N NAassociated measurement uncertainty and therefore traceability does not need to be demonstrated.






Requirement


ComplianceComments

Y N NAT4. Policy for traceability obtained through a reference material (RM) and certified reference material (CRM)Values associated with RMs may not be metrologically traceable. Values associated with CRMs are, by definition, metrologically traceable.

Traceability is considered to have been established where:

g) The values assigned to CRMs are produced by NMIs and included in the BIPM KCDB or produced by an a ccr e d i t e d R e f eren c e M a te r i a l P r o d u c er (RMP) under its accredited scope of accreditation to ISO Guide 34:2009.Note: RMPs accredited by a signatory to a regional body e.g. Asia Pacific

Laboratory Cooperation (APLAC), are considered to have established valid traceability.

h) The values assigned to CRMs covered by e ntr i es i n t h e JC T LM database are considered to have established valid traceability.

i) The majority of RMs and CRMs are produced by other RMPs. These can be considered as critical consumables and the facility shall demonstrate that each RM or CRM is suitable for its intended use as required by clause 4.6.2 in ISO/IEC 17025:2005 or clause 4.6 in ISO 15189:2012.






Requirement


ComplianceComments

Y N NAPolicy on: Special Circumstances

GAC recognizes that there are circumstances where a non-accredited laboratory must be used even when an accredited laboratory is available to perform the calibration. An exception to (T1) is allowed under the following special circumstances:

1. Cases where the reference standard or M&TE warranty from the Original Equipment Manufacturer (OEM) will be deemed null and void should another calibration provider other than the OEM be used. Evidence of the warranty shall be maintained by the CAB.

*

2. Cases where the calibration must be performed by the OEM since proprietary software is needed to perform the calibration which is not made available by the OEM to the public through policy or pricing. Evidence that use of such software is required for the performance of the calibration shall be maintained by the CAB.

*

3. Cases where a piece of equipment is newly purchased with a non-accredited OEM calibration (Note: Implementation begins with CABs that have an anniversary date of April 30, 2016 or later or new applications received after April 30, 2015).






Requirement


ComplianceComments

Y N NAPolicy: Exceptions and Calibration Interval

In cases where the calibration interval of the reference standard or M&TE is set at greater than two years, and it exceeds the manufacturer’s recommended interval, documented evidence (e.g. records of intermediate checks) indicating that the reference standard or M&TE continues to remain within the manufacturer (or applicable) specification is also required.

Note: this does not apply for reference standards or M&TE where traceability is established through the use of certified reference materials, intrinsic standards or consensus standards.

*

NOTE TO ASSESSORS: _____Check here if the organization does not utilize (T4) In-house Calibrations. The remainder of (T5) will then be considered “NA”. Please skip to section (T6)

T5 In-house Calibrations

An in-house calibration is the calibration of a GAC accredited CAB’s own reference standards or measuring and test equipment by the laboratory’s own staff for which the calibration measurement parameters ARE NOT included on their Scope of Accreditation.

Note: This should not be confused with an internal calibration. In this case (T5) is not applicable; rather (T1) and (T6) of this document applies. (Note: Implementation begins with CABs that have an anniversary date of April 30, 2016 or later or new applications received after April 30, 2015).






Requirement


ComplianceComments

Y N NA

For all in-house calibrations having a significant effect on the accuracy or validity of the result of the accredited test, calibration or sampling on the CAB’s GAC Scope of Accreditation:

1. The CAB shall maintain documented procedures for the in-house calibrations;

2. The in-house calibrations shall be evidenced by a calibration report, certificate, or sticker, or other suitable method;

*

3. Calibration records shall be retained minimally for the length of time between full GAC assessments;

*

4. The CAB shall maintain training records for calibration personnel and these records shall demonstrate the technical competence of the personnel performing the calibrations: evidence of competence includes, for example, documented training and the results of measurement audits;

*






Requirement


ComplianceComments

Y N NA5. The CAB shall be able to demonstrate traceability to national or

international standards of measurement by procuring calibration services from appropriately accredited calibration labs or an NMI for the reference standard used to perform the in-house calibration;

6. Where available, the CAB shall use reference materials from accredited reference material producers or an NMI;

*

7. Measurement uncertainty:

a) The CAB shall have and apply a procedure for evaluating measurement uncertainty;

b) Measurement uncertainty shall be calculated in accordance with the GUM2 for each type of calibration. The data from which the origin of the uncertainty was determined shall be documented and the assumptions made for the determination of the uncertainty shall be specified and documented. (Note: Implementation begins with CABs that have an anniversary date of April 30, 2016 or later or new applications received after April 30, 2015.);

*

c) Measurement uncertainty shall be taken into account when statements of compliance with specifications are made;

*

2 JCGM 100:2008 Guide for the Expression of Uncertainty in Measurement.Version: 1 Page 10 of 16





Requirement


ComplianceComments

Y N NAd) At a minimum, all uncertainty analysis shall take into

consideration the following contributors and documentation of the consideration shall be made. (Note: Implementation begins with CABs that have an anniversary date of April 30, 2016 or later or new applications received after April 30, 2015):

1. Repeatability;2. Resolution3;3. Reference standard uncertainty;4. Reference standard stability;5. Environmental factors

*

8. Reference standards shall be recalibrated at appropriate intervals to ensure that the reference value is reliable.

*

9. The CAB shall have a policy or procedure for establishing and changing calibration intervals which shall be based on the historical behavior of the reference standard4 (Note: Implementation begins with CABs that have an anniversary date of April 30, 2016 or later or new applications received after April 30, 2015).

3 It should be noted that uncertainty components, such as resolution, may also contribute to other components such as repeatability. Therefore simply combining all components on an equal basis could result in an overstatement of the measurement uncertainty.4 See, for example, NCSLI RP-1 "Establishment & Adjustment of Calibration Intervals" (3/96).






Requirement


ComplianceComments

Y N NA

T6 Accredited (Endorsed) Calibration Certificates (or equivalent) GAC requires that:

1. The external calibration of all reference standards and M&TE having a significant effect on the accuracy or validity of the result of the accredited test, calibration or sampling shall be recorded in a calibration certificate or report and shall include:

a) An endorsement by the recognized AB’s symbol (or other reference to accredited status by a specific, recognized AB); and

b) The accreditation certificate number assigned by the AB; andc) A statement of traceability; and

d) A statement of the measurement result and the associated uncertainty5 that meets the requirements of ILAC P14:01/2013 ILAC Policy for Uncertainty in Calibration . These uncertainties shall include an explanation of the meaning of the uncertainty statement and be reported as the expanded uncertainty with a defined coverage factor, k (typically k = 2) and the confidence interval (typically to approximate the 95% confidence level).




http://www.ilac.org/documents/ILAC_P14_01_2013.pdf

http://www.ilac.org/documents/ILAC_P14_01_2013.pdf



Requirement


ComplianceComments

Y N NA2. When Test Uncertainty Ratios (TURs) are reported, they shall be

calculated using the expanded uncertainty of the measurement, not the “collective uncertainty of the measurement standards”; these implicit uncertainty statements shall be accompanied by words to the effect that the TUR was calculated using the expanded measurement uncertainty. In addition, the coverage factor and confidence interval shall also be stated (e.g. expressed at approximately the 95% confidence level using a coverage factor of k=2).

1. For external calibrations performed by an NMI, these shall be recorded in a calibration certificate or report and shall include:a) An endorsement by the NMI; andb) A statement of the measurement result; andc) The associated measurement uncertainty.

5 See “GAC FAD 3 Supplementary requirements for calibration and measurement” for exceptions on including the measurement uncertainty.






Requirement


ComplianceComments

Y N NAT7 Accredited (Endorsed) Reference Material Certificates

1. Accredited6 reference materials shall be accompanied by a certificate meeting the requirements of ISO Guide 31. This certificate shall also include:a) An endorsement by the AB’s symbol (or other reference to

accredited status by a specific, recognized AB); and b) The accreditation certificate number assigned by the AB.

2. Reference materials obtained from an NMI shall include an endorsement by the NMI.

Note: It is common practice for a reference material producer to package their reference materials under a different organization’s name. In these instances, it is possible for the reference materials to meet GAC technical note 2 if the accompanying certificate includes reference to the specific, recognized accreditation body, and the accreditation certificate number.

6 Accredited reference materials are those provided from a reference material producer that is accredited to ISO Guide 34 by an AB that is recognized by the Asia Pacific Laboratory Accreditation Cooperation (APLAC) www.aplac.org.






Requirement


ComplianceComments

Y N NANOTE TO ASSESSORS: _____Check here if the organization does not utilize (T8) Intrinsic Standards. The remainder of (T8) will then be considered “NA”. Please skip to section (T9)

T8 Intrinsic Standards

Where an intrinsic standard or system is used as a reference standard, the following requirements apply:

1. Direct intrinsic standard or system-to-intrinsic standard or system comparison with NMI or an accredited laboratory shall be conducted at appropriate intervals to ensure the correct realization of the measurand;

2. Documented calibration history of the device used to measure differences between intrinsic standard or system and unknown values shall be maintained;

3. Documented calibration history of the intrinsic standard or system components (e.g., the time base of the reference frequency counter in a Josephson voltage array system) shall be maintained;






Requirement


ComplianceComments

Y N NA4. Documented evidence of periodic checks on system precision and

stability (e.g., leakage currents, ground loops, thermal emf’s, step integrity, trapped magnetic flux, noise, and microwave power impinging on a Josephson voltage array) shall be maintained.

Note: For those laboratories using saturated salt solutions for the purposes of traceability, those solutions mixed on demand from reagent grade salts and distilled water may be treated as comparable to an intrinsic standard. In these instances, the laboratories are not required to meet item (1) as listed above, but must be able to provide evidence of meeting (2) through (4).

T9 Dimensional Testing

GAC requires that the dimensional testing laboratory shall comply with GAC FAD 3 Supplementary requirements for calibration and measurement in cases where the dimensional artifact serves as a link in the traceability chain.




Documents

C105 – GENERAL CHECKLIST: A2LA POLICY ON ...gcc-accreditation.net/uploads/site_documents/AC/Forms/AC... · Web viewThese uncertainties shall include an explanation of the meaning